us patent prosecution duty to disclose · reference is necessarily material because a finding of...

US Patent Prosecution Duty to Disclose

July 12, 2016

Terri Shieh-Newton, Member

IP Summer Academy 2016


Boston, Massachusetts

July 11 – 22, 2016


© 2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Duty to Disclose

2

Therasense v. Becton Dickinson & Co., (Fed. Cir. en banc May 25, 2011)

• Federal Circuit en banc established new standards for establishing both 10 materiality and 2)

intent for a showing of inequitable conduct

Materiality:

• Federal Circuit en banc established a “but-for” materiality standard

• In addition to “but-for” test as a general rule, also cases where patentee has engaged in

“cases of affirmative egregious misconduct” such as the filing of unmistakably false affidavit,

the misconduct is material

• Federal Circuit rejected PTO’s current standard for materiality under 37 CFR 1.56

•Question whether “sliding scale” of materiality/intent still proper analysis



July 11 – 22, 2016



Duty to Disclose

3

Therasense v. Becton Dickinson & Co., (Fed. Cir. en banc May 25, 2011)

Intent:

• Federal Circuit en banc also articulated “knowing and deliberate” standard for intent to

deceive



July 11 – 22, 2016



Duty to Disclose

4

Therasense v. Becton Dickinson & Co. – continued

• Federal Circuit’s “But for” test for materiality:

•When an applicant fails to disclose prior art to the PTO, the prior art is but-for material id the PTO would not have allowed a claim had it been aware of the undisclosed prior art

•Hence, in assessing the materiality of a withheld reference, the court must determine whether

the PTO would have allowed the claim if it had been aware of the undisclosed reference. In making this patentability determination, the court should apply the preponderance of the evidence standard and give claims their broadest reasonable construction …

•Often the patentability of a claim will be congruent with the validity determination – if a claim is properly invalidated in district court based on deliberately withheld reference, then that

reference is necessarily material because a finding of invalidity in a district court requires a clear and convincing evidence, a higher evidentiary standard than that used in prosecution at the PTO.

•However, even if a district court does not invalidate a claim based on a deliberately withheld reference, the reference may be material if it would have blocked the patent issuance under

the PTO’s different evidentiary standard.



July 11 – 22, 2016



Duty to Disclose

5


• Federal Circuit’s “knowing and deliberate” standard for intent to deceive

– The district court found intent to deceive based on the absence of a good faith explanation for failing to

disclose the EPO briefs.

– However, a “patentee need not offer any good faith explanation unless the accused infringer first . . .

prove[s] a threshold level of intent to deceive by clear and convincing evidence.” Star, 537 F.3d at 1368.

The district court also relied upon the “should have known” negligence standard in reaching its finding of

intent. See Trial Opinion at 1113 (“Attorney Pope knew or should have known that the withheld information

would have been highly material to the examiner”).

– Because the district court did not find intent to deceive under the knowing and deliberate standard set

forth in this opinion, this court vacates the district court’s findings of intent. Id. at 1113-16. On remand, the

district court should determine whether there is clear and convincing evidence demonstrating that

Sanghera or Pope knew of the EPO briefs, knew of their materiality, and made the conscious decision not to

disclose them in order to deceive the PTO.



July 11 – 22, 2016



Duty to Disclose

6


•On May 27, 2011, USPTO issued press release:

“We are now studying the potential impact of Therasense v. Becton Dickinson on Office practice, and

we expect to soon issue guidance to applicants regarding the materials they must submit to the Office

under their duty of disclosure.”



July 11 – 22, 2016



Duty to Disclose

7

• Ensures that PTO has the information it needs to effectively examine the patent application

•Without this duty, a patent might issue to undeserving applicants and inventions, which would

unfairly exclude public from making, using and selling claimed invention

•VIOLATION OF DUTY - INEQUITABLE CONDUCT

– U.S. PTO does not investigate inequitable conduct violations

• This issue is decided in U.S. courts when a person challenging the validity of a patent asserts

that the patentee has engaged in inequitable conduct



July 11 – 22, 2016



Duty to Disclose

8

• If inequitable conduct is found, the entire patent is unenforceable, even if the inequitable

conduct relates to only one claim (see MPEP § 2016)

– Examples: Submitting misleading information (e.g., false test data) in order to intentionally mislead the PTO

– Intentional concealment of a relevant prior art reference

•Other patents which are related to unenforceable patent (e.g., continuation patents) may

also be held unenforceable if fraudulent conduct affects the other patent (e.g., failure to

submit a relevant reference in parent application which is also relevant in a continuation

application)



July 11 – 22, 2016



Duty to Disclose

9

•WHO HAS DUTY

– Each individual associated with the filing or prosecution of the patent application (see 37 C.F.R. § 1.56(c))

• Each inventor named in the application

• Each U.S. attorney or agent, who prepares or prosecutes the application

• Every other person who is substantially involved in the preparation or prosecution of the application and who is

associated with the inventor, the assignee, or with anyone to whom there is an obligation to assign the application



July 11 – 22, 2016



Duty to Disclose

10

•Members of the Company Patent Section who work on the application

•Non-U.S. attorney who work on the application

– Non-U.S. patent attorneys have a duty to disclose material information cited in foreign applications (see

MPEP § 2004 and Molins PLC v. Textron, Inc., 33 USPQ2d 1823 (Fed. Cir. 1995) - British patent attorney

violated the duty to disclose by his failure to submit a reference cited in a foreign patent office)

– Individuals other than the U.S. attorney, agent, or inventor can satisfy the duty by disclosing information to

the U.S. attorney, agent, or inventor (see 37 C.F.R. § 1.56(d) and MPEP § 2002.01)



July 11 – 22, 2016



Duty to Disclose

11

•Duty only applies to individuals, not to organizations, companies, etc.

•WHAT IS MATERIAL

– Current Rule 56(b) - effective March 16, 1992

• Information which is not cumulative to information of

record in the application, and

• It (i) helps establish a prima facie case of unpatentability, or (ii) is inconsistent with arguments made by the

applicant to the PTO regarding patentability

– Information is not material if it is less relevant than, or cumulative to, prior art which was considered by the

PTO



July 11 – 22, 2016



Duty to Disclose

12

• Information is not material if it is not prior art under at least one section if 35 U.S.C. § 102 (e.g., a

publication which is published after the U.S. filing date)

•Non-material information does not have to be submitted to the PTO

• Examples of Material Info. (see MPEP § 2001.04)

– U.S. patents and published patent applications

– Other pending U.S. and non-U.S. patent applications including cited prior art, search reports, and office

actions (see 37 C.F.R. 1.56(a)(1), MPEP § 2001.06(a), and Dayco Products v. TCI, 329 F.3d 1358 (Fed. Cir.

2003))



July 11 – 22, 2016



Duty to Disclose

13

• Issued / published patent applications from all countries

•Public uses, sales, and offers to sell of any product which contains some or all of the elements

of the claimed invention

• Technical publications

• Information related to inventorship disputes

• There is no duty to disclose information which is favorable to patentability (e.g., evidence of

commercial success), and information related to the level of skill in the art (see MPEP

§ 2001.04)



July 11 – 22, 2016



Duty to Disclose

14

•WHAT TO SUBMIT

– Related U.S. applications

• Submit the existence of the related application cited prior art, and rejections (see MPEP § 2001.06(b))

• Even if the examiner in the other application(s) is the same, do not assume that he will remember the other

application and references cited in the other application

• Dayco Products v. TCI (see above) held that rejections of “substantially similar” claim is “material” information ⇨

submit office actions and search reports!

• See also Larson Mfg. Co. v. Aluminart Products Ltd. (Fed. Cir. 2009) (held inequitable conduct based on failure to

submit rejection in co-pending case)



July 11 – 22, 2016



Duty to Disclose

15

•Related Non-U.S. Applications

•Prior art search reports and rejections in related foreign applications (see 37 C.F.R. 1.56(a)(1),

MPEP § 2001.06(a), and Dayco v. TCI)

•Conflicting arguments made to other (non-U.S.) Patent Offices



July 11 – 22, 2016



Duty to Disclose

16

•Related litigations

• Information from litigation related to subject matter of patent application (see MPEP §

2001.06(c))

– The existence of the litigation

– Evidence of prior public use or sales

– Questions of inventorship

– Prior art relied on in an assertion of invalidity

– Allegations of fraud, inequitable conduct, or violation of duty to disclose

– This information can be disclosed by filing a copy of the court papers related to this information



July 11 – 22, 2016



Duty to Disclose

17

•Other information to submit

– Marketing and sales information

– Information from conventions / trade shows

– Submissions to other government agencies (e.g., FDA – see Bruno Independent Living Aids Inc. v. Alcorn

Mobility Services, 394 F.3d. 1348 (Fed. Cir. 2005))

•HOW TO SATISFY THE DUTY

– Submit all information known to be material to the patentability of the application in an Information

Disclosure Statement in time to be considered by Examiner (see Part II)



July 11 – 22, 2016



Duty to Disclose

18

• There is no duty to perform search, only need to disclose information that is known

•RECOMMENDATIONS

– If materiality is unclear, submit reference and let PTO decide

– If you are not sure reference is prior art, submit reference and let PTO or U.S. attorney decide

– Forward all references cited in counterpart and related non-U.S. applications to U.S. patent attorney ASAP

– Keep in mind that patent term adjustment (PTA) can be affected by when the IDS is submitted – PTA can

be very valuable for some patents



July 11 – 22, 2016



Duty to Disclose

19

• Submit prior art which is material to broadest claim, not just information which is only material

to the focus of the invention

•Patents are strengthened by submitting a lot of references

• Submission of references avoids later questions of materiality and intent to deceive (which can

be very expensive to defend in litigation) accurately, do not mischaracterize (report failures

too)

•Reporting experimental results



July 11 – 22, 2016



Duty to Disclose

20

•Avoid filing very long lists of prior art references. Filing large numbers of less relevant references

along with a smaller number of more relevant references can be considered to be an attempt

to hide the more relevant references2

• If a long list of references is filed, indicate the ones which are more relevant

•When filing CIP applications, don't forget to submit references which may not be prior art in the

parent application, but may be prior art for the new matter

2 See Penn Yan Boats, Inc, v. Sea Lark Boats, Inc., 175 USPQ 260, affd, 178 USPQ 577, cert.

denied 414 U.S. 874 (1974)



July 11 – 22, 2016



Duty to Disclose

21

• If prior art references are considered by Company's Patent person/ Non U.S. Agent, but not

submitted because it is believed that they are not material, record this fact in file

•A copy of U.S. patent references do not have to be supplied

•References not in English

– A concise English explanation of relevant portions is required



July 11 – 22, 2016



Duty to Disclose

22

• Submission of English Abstract is not recommended unless Abstract describes all relevant

portions of reference (Semiconductor Energy Laboratory Co. v. Samsung Electronics Co., Fed.

Cir. 2000)

• English translation must be filed if it is readily available (already in existence) to anyone

associated with the prosecution of the application (see 37 C.F.R. § 1.98(c)) – Machine

translations are arguably “already in existence”

• English Search Report that cites reference can be used



July 11 – 22, 2016



Duty to Disclose

23

• INFORMATION DISCLOSURE STATEMENT - IDS

– WHEN TO FILE

• Within 3 months of filing date or before 1st Office Action on the merits (whichever occurs last) (37 C.F.R. § 1.97(b))

– No fee or certification required, IDS is always considered by Examiner

– Restriction Requirement and Election of Species Requirement are not office actions on the merits



July 11 – 22, 2016



Duty to Disclose

24

•Before mailing date of final office action or notice of allowance (37 C.F.R. § 1.97(c))

– Must file a certification, OR pay a fee to have IDS considered by Examiner

– Certification must state (see 37 C.F.R. § 1.97(e)):

• i) That each item in the IDS was cited in communication from another patent office in a counterpart application

not more than 3 months from filing of the IDS, or



July 11 – 22, 2016



Duty to Disclose

25

• ii) No item in the IDS was known to anyone associated with the application (see 37 C.F.R.

§1.57(c)) more than 3 months before filing the IDS

•RECOMMENDATION

• If part (i) cannot be certified it is better to just pay the fee since it is difficult to positively certify part (ii)

•After mailing date of final office action or notice of allowance, but before payment of issue

fee (37 C.F.R. § 1.97(d))

– Must file a certification under 37 C.F.R. § 1.97(e) (see III.A.2.b. above) AND pay a fee to have IDS considered



July 11 – 22, 2016



Duty to Disclose

26

•After mailing date of final office action or notice of allowance, but before issue date if

CANNOT file under (37 C.F.R. § 1.97(d)) (i.e. after pay issue fee or cannot certify)

– IDS will be place in file wrapper, but will NOT be considered by Examiner

– Duty to disclose is satisfied

– Must file a continuation application / Petition to Withdraw from Issue + RCE in order to have IDS considered

by the Examiner (see 37 C.F.R. § 1.313(b)(5))



July 11 – 22, 2016



Duty to Disclose

27

•After Issue Date

– Patentee or any third person can make any patent or printed publication of record in a patent file by filing

a prior art statement under 37 C.F.R. § 1.501 at any time during the term of the patent

– Statement filed by patentee can include a statement which explains how the claims are different than the

prior art reference

– There is NO duty to submit any information after issue date

– If prior art is very relevant, can submit in Reexam



July 11 – 22, 2016



Effect of IDS on Patent Term Adjustment (PTA)

28

• 37 CFR 1.704(a): "The period of adjustment of the term of a patent under § 1.703(a) through (e) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application."

• Under 1.704(d)(1), IDS submissions will not be considered to be failure to engage in reasonable efforts to conclude prosecution if one of two certifications are made:

1.74(d)(1)(i): “That each item of information contained in the information disclosure statement was first cited in any communication from a patent office in a counterpart foreign or international application or from the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement."

1.74(d)(1)(ii): “That each item of information contained in the information disclosure statement is a communication that was issued by a patent office in a counterpart foreign or international application or by the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement."

Note that the time period for these certifications is thirty (30) days and not one month.



July 11 – 22, 2016



IDS Filing Timeline

29



July 11 – 22, 2016



IDS Timing Strategies

30

• I have a pending Office Action. Should I file an IDS now?

Non-final OA: Unless you would lose a certification option, typically wait to file IDS until you file a Response (consider PTA effects or in case the client decides to abandon in the meantime)

Final OA: Unless you would lose a certification option, wait until you know whether you will be filing an RCE, which would make the IDS free

• I have a Notice of Allowance, but there is uncited art. Help!

More conservative: File IDS and RCE to ensure consideration of references

Less conservative and more time consuming: Evaluate content of uncited art to determine whether it is cumulative (need not be cited) or is not material to the allowed claims (need not be cited). If you end up not citing the art, put a note in the file indicating that the art was reviewed but determined to not be material/is cumulative/etc.

• My case in on appeal, but I have art to cite. Help!

Examiners will not consider an IDS when a case is on appeal, so wait to file.

HOWEVER, some Examiners will consider an IDS filed when the appeal was pending if the Examiner must prepare a new action because the appeal is withdrawn or the PTAB reverses the Examiner.



July 11 – 22, 2016



Quick Path IDS (QPIDS)

31

• Pilot program currently set to expire September 30, 2015

• Used to submit references after issue fee payment

• IDS is filed with a “conditional” RCE

• The Examiner will consider the IDS and decide whether prosecution needs to be reopened

based on any item cited in the IDS

• If the Examiner decides not to reopen prosecution, the RCE fee will not be charged and the

“conditional” RCE will not be processed

• MUST make a 1.97(e) certification for participation in this program

• http://www.uspto.gov/patent/initiatives/quick-path-information-disclosure-statement-qpids



July 11 – 22, 2016



Duty to Disclose

32

•RECOMMENDATION

– Submit IDS within 3 months of U.S. filing date in order to b e sure that references always will be considered

by Examiner and/or with responses (consider doing SIDS sweep when an Office Action arrives)

•WHAT TO INCLUDE IN IDS - 37 C.F.R. § 1.98

– A list of all patents, publications, etc. which are being submitted for consideration by the PTO (PTO Form

1449)

• U.S. patents should be identified by inventor, patent number, and issue date

• Non-U.S. patents and published patent applications should be identified by country, document number, and

publication date



July 11 – 22, 2016



Duty to Disclose

33

•Publications should be identified by author, title, relevant pages, and date and place of

publication (see 37 C.F.R. § 1.98(b))

•A copy of each reference - U.S. patent applications do not have to be supplied (37 C.F.R.

§1.98(a)(2)(iii))

•References not in English

– A concise explanation of the relevance of each ref.

– Concise explanation can be included in the patent specification

– English Search Report that cites reference



July 11 – 22, 2016



Duty to Disclose

34

• English translation must be filed if it is readily available (already in existence) to anyone

associated with the prosecution of the application (see 37 C.F.R. § 1.98(c))

•Copy of reference is not required if it was cited by, or submitted to, the PTO in a prior U.S.

application which is being relied on for domestic priority under 35 U.S.C. § 120 (e.g., a

continuation application, see 37 C.F.R. § 1.98(d))

• If any references are cumulative, copies of only one of the cumulative references can be filed

(see 37 C.F.R. § 1.98(c))



July 11 – 22, 2016



Duty to Disclose

35

•VIOLATION OF DUTY

– HOW TO PROVE

• Patent challenger must prove by clear and convincing evidence3 that

– The applicant withheld material (relevant) information from, or made a material misrepresentation to the PTOs.

– The applicant knew of the undisclosed information or misrepresentation and it's materiality, and

– The applicant intended to mislead the PTO

3 Evidence which establishes that the truth of the facts asserted is highly probable.



July 11 – 22, 2016



Duty to Disclose

36

•Materiality and intent must always, be shown

•Good faith (honest) failure to submit a reference, good faith misrepresentation to the PTO

(e.g., false statement in oath), or good faith mistake (e.g., failure of inventor to understand a

declaration) does NOT constitute inequitable conduct

•BALANCING INTENT AND MATERIALITY4 - SEE CHART I

– First, the court decides whether the materiality of the withheld information exceeds a threshold level (see

Point A)

4 See Halliburton Co. v. Schlumberger Technology Corp., 17 USPQ2d 1834 (Fed. Cir. 1991).



July 11 – 22, 2016



Duty to Disclose

37

• If the threshold level of materiality is exceeded, the court decides whether the applicant's

conduct exceeds a threshold level of intent (see Point B)

• If the threshold levels of materiality and intent are exceeded, the court then balances the

materiality and intent

• If the withheld information or misrepresentation is less material, a greater degree of intent must

be proven (see Point C)

• If withheld information is more material, a lesser degree of intent is required (see Point D)



July 11 – 22, 2016



Duty to Disclose

38

•MATERIALITY

– As defined above in Therasense (and presumably 37 C.F.R. § 1.56 as will be revised)

• INTENT5

– Intent does not have to be proven with direct evidence e.g., a statement by the applicant that he

intended to mislead the PTO is not required)

– Usually, intent is proven by showing that the applicant should have known of the materiality of the withheld

reference or misrepresentation (see Bruno v. Acorn above)

5 See Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 9 USPQ2d 1384 (Fed. Cir. 1984).



July 11 – 22, 2016



Duty to Disclose

39

• Failure to submit to the PTO a reference that was cited in another patent office may create an

inference that the failure to submit the reference was intentional (see Molins, above)

• If withheld information or misrepresentation is highly

material, then intent to deceive may be inferred (see Jack Frost Laboratories, Inc. v. Physicians

& Nurses Mfg. Corp., 901 F. Supp. 718 (S.D.N.Y. 1995))

•Once intent is inferred, patentee must present evidence that they did not intend to deceive

the PTO, a mere denial of intent to deceive will not defeat a finding of inequitable conduct



July 11 – 22, 2016



Duty to Disclose

40



July 11 – 22, 2016



Duty to Disclose - Appendix

41

•Post-Therasense Cases

– Powell v. Home Depot U.S.A., Inc. (Fed. Cir. 2011)

– American Calcar, Inc. v. American Honda Motor Co., Inc. (Fed. Cir. 2011)

– August Tech. Corp. v. Camtek, Ltd. (Fed. Cir. 2011)

– Cordis Corp. v. Boston Sci. Corp. (Fed. Cir. 2011)

– Aventis Pharma S.A. v. Hospira, Inc. (Fed. Cir. 2012)

•AIA: Supplemental Examination

– Patent shall not be found unenforceable based on information considered in supplemental examination

– It is, however, inapplicable to cure existing allegations

– It will take effect on 9/16/2012



July 11 – 22, 2016



Duty to Disclose - Appendix

42

• Therasense standard

– Materiality and intent are separate requirements. (No more sliding scale approach).

– To satisfy the materiality requirement, it must be proved that if the PTO had been aware of an undisclosed

prior art reference, the PTO would not have allowed a claim unless there is affirmative egregious

misconduct such as filing of an unmistakably false affidavit. (but-for standard)

– To satisfy the intent requirement, it must be proved that the patent applicant knew of the reference, knew

that it was material, and made a deliberate decision to withhold it. (specific intent standard)



July 11 – 22, 2016



American Calcar, Inc. v. American Honda Motor Co., Inc.

43

•During prosecution of a patent application, American Calcar, Inc. (ACI) did not disclose a

document.

•During litigation, ACI alleged that it did not disclose because the document is cumulative, but

the court found that it is not cumulative and found that it is critically important document for

patentability determination.

•Honda argued that ACI intended to deceive USPTO because the undisclosed document is

critically important in patentability determination.



July 11 – 22, 2016



Powell v. Home Depot U.S.A., Inc.

44

•Powell presented a prototype to Home Depot.

•Powell filed a patent application. During prosecution, he filed a Petition to Make Special on

the ground that he was obligated to manufacture and supply devices embodying the claims

sought.

•Negotiation between Powell and Home Depot failed and Home Depot contacted another

company to build an alternative.

•Powell did not inform the PTO that he no longer qualified to get the Special designation.

•But-for material?



July 11 – 22, 2016



August Tech. Corp. v. Camtek, Ltd.

45

•During prosecution of an August Tech's patent, the inventors did not submit to the PTO

information about August Tech's NSX-80 wafer inspection device.

•During litigation, Camtek argued that August Tech's patent claims are invalid on the ground

that (i) August Tech's NSX-80 wafer inspection device is a 102(b) prior art, (ii) the NSX-80 device

in combination with other prior art references would have made the patent claims obvious.

Camtek also argued that the patent claims should be found unenforceable because the NSX-

80 information was not submitted.




July 11 – 22, 2016



Aventis Pharma S.A. v. Hospira, Inc.

46

•During prosecution of a patent, the inventors did not submit two prior art references.

•During litigation, the court found the patent invalid over the two references. The inventors

testified that he did not submit the references because they described only "failed

experiments."


• Specific intent?



July 11 – 22, 2016



Cordis Corp. v. Boston Sci. Corp.

47

•During prosecution of a EP counterpart patent application, the inventors received a EP Search

Report (ESR). In the ESR, a reference A was identified as category "X" and a reference B was

identified category "Y." ESR was accompanied by their attorney's letter stating that the only

reference particularly relevant is A.

•During prosecution of a U.S. patent application, the inventors submitted A to the PTO, but did

not submit B.

•During prosecution of a U.S. continuation application, the inventors submitted A and B to the

PTO.

• Specific intent?


Thank you!

48

us patent prosecution duty to disclose · reference is necessarily material because a finding of...

Documents